510(k) · Cleared
ClearedExcilon Amd Antimicrobial Sponge Model #7088
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company · FRO Dressing, Wound, Drug
Cleared on Aug 22, 2001 as substantially equivalent to K990530 (The Kendall Company, L.P., 2000) and 1 other predicate after a 62-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Aug 22, 2001
- Review
- 62 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914579 (1992). 9 ancestors in all, the oldest K820198 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK983833 Acticoat Composite Wound Dressing, Acticoat Composite Wound…Westaim Biomedical, Inc. · 1998
- 1 generation backK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- This deviceK011941 Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001
- Descendant · cites it directly · 0 of its ownK070685 Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
Most influential descendants
Showing 1 of 1 · See all- K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive | Westaim Biomedical, Inc. | 1998 | — |
| −1 | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| 0 (this device) | K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | The Kendall Company | 2001 | — |
| +1 | K070685 | Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990530 | Kerlix MD Antimicrobial Gauze Dressing Our OCR of the scanned summary read K980530, FDA’s number for Peregrine Fiber Optic Bipolar Straight Pick and Angled… (Peregrine Surgical, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kendall Kerlix AMD Antimicrobial Gauze”. | 2000 |
| * | K992221 | Acticoat Primary Antimicrobial DressingSummary page 5…in intended use, function and composition to the Kendall Kerlix AMD Antimicrobial Gauze, 510(k) No. K980530 and the Acticoat® Primary Antimicrobial Dressing, 510(k) No. K992221. Device Description The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single us¢ wound dressing consistin… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070685 | Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K070685 (Tyco Healthcare, 2007) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K990530.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Primary dressing for IV sites, tracheostomy tube sites, chest tube sites,
catheter and drain sites.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011941: Excilon Amd Antimicrobial Sponge Model #7088.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011941
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026